In 2003, the International Diabetes Foundation estimated that there were 194 million people worldwide with diabetes mellitus. It further estimated that another 314 million people worldwide had impaired glucose tolerance or “pre-diabetes,” a condition that often precedes diabetes. Both of these figures are expected to rise significantly by the year 2025. In the United States alone, it is estimated that 23.6 million children and adults—nearly 8% of the country's population—have diabetes, while another 57 million people have pre-diabetes.
Diabetes mellitus (“diabetes”) is one of the leading causes of premature illness and death in most countries, due in part to the increased risk of cardiovascular disease that is associated with diabetes. Diabetes is also among the leading causes of kidney failure, blindness, visual disability, and non-traumatic amputation of the lower limbs. The chronic nature of diabetes also makes it a costly disease. In 2007, it was estimated that in the United States, the total costs of diagnosed diabetes, including direct medical costs and indirect costs due to disability, work loss, and premature mortality, totaled $174 billion.
Currently, diabetes is generally treated using one or a combination of medications including sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and DPP-4 inhibitors. However, existing diabetes medications are associated with various disadvantages such as side effects, short half-life, and/or negative interactions with other drugs.
Thus, there exists a need for new and effective medications and/or combinations of medications for the treatment of diabetes. The present invention addresses this and other needs.